Free ISO 13485 Resources

Ready to build the full system?

The free tools show you where you stand. The ISO 13485 Starter Kit gives you the six core kits (gap assessment, quality manual, document control, CAPA, internal audit and training), and the ISO 13485 Foundations course teaches every clause with worksheets, unlimited access and a certificate of completion.

See the Starter Kit See ISO 13485 courses

Free ISO 13485 Resources for Medical Device Companies

Start building a stronger medical device quality management system with practical free tools designed around real ISO 13485 implementation work. These free resources help you assess your current system, structure your documentation, understand design history file expectations and start corrective action workflows before you move into full implementation packs.

What You Will Find in This Collection

  • Gap assessment lite for an early-stage system review
  • Master document list template
  • CAPA initiation checklist
  • DHF audit checklist and index

Who This Collection Is For

  • Medical device startups building their first QMS
  • QA/RA professionals benchmarking current system gaps
  • Teams deciding which paid toolkit or course to buy next

Use These Resources to Move Faster

Download the free tools, apply them to your current system, then move into the matching ISO 13485 template kits for full implementation, or the ISO 13485 Lead Implementer course if you are leading the project.

Three ways to buy ISO 13485 templates

Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.

Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment WorkbookStarter Kit Core system: 6 kits for clauses 4 to 6 and 8 $249 $504View Starter KitBest valueComplete QMS Kit All 15 kits, including design, risk and production $449 $1,375View Complete QMS Kit
Gap assessment, 71 requirement areas with action plan
Quality manual and management review kit
Document control and records kit
CAPA and nonconformance kit
Internal audit kit
Training and competence kit (8 modules)
Design controls and DHF kit, ISO 14971 risk management file kit
Supplier control, production and traceability, equipment and calibration kits
Software validation, medical device file and labelling kits
Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack
Start-here roadmap to certification
Optional 60-minute onboarding call with the author
30-day money-back guarantee, instant download, one-organization licence, free updates for this edition

Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?

Instant downloadFiles by email within minutes
Fully editableWord, Excel, PowerPoint. No macros
30-day money-back guaranteeDoesn't fit your system? Full refund, no fuss
Free updatesRevised files sent free when the standard changes

Not sure which ISO 13485 kit you need?

Run the free ISO 13485 gap assessment to see where you stand, then compare the Starter Kit, the Complete Kit and the individual kits side by side.

Compare ISO 13485 kitsSee free sample pages